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Based on available mechanistic and clinical information, the investigators propose a nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The investigators' purpose is to evaluate the effect of succinylcholine on patients taking statins. Patients scheduled to undergo elective surgery (other then orthopedic, spinal, vascular or muscle) with planned endotracheal intubation will be approached regarding participation in the trial. Design of the study is complex because there is no way to randomize patients to statins or no statins and also no way to take them off the statins prior surgery. So statin use will not be randomized; confounding factors will be accounted for by stratification (every 10 years of age from 40-80 and gender) and statistical adjustment. The investigators propose to test the hypothesis that succinylcholine administration increases plasma myoglobin concentration more in patients who are on statins compared to patients who do not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin use group | Other | Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. |
|
| non statin use | Other | Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Succinylcholine | Drug | Succinylcholine will be administered pre-induction over a period of 5 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Myoglobin Concentration | induction, 5 minutes after administration, 20 minutes and 24 hours post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Pain | verbal rating scale score and the pain score both at 2 and 24 hours postoperatively. The verbal rating scale score ranges from 0 (no pain) to 100 (worst pain imaginable). The pain score ranges from 0 to 3: 0 none; 1 muscle stiffness or pain in the nape of the neck, shoulders, and chest; 2 muscle stiffness and pain requiring analgesia; and 3 incapacitating generalized muscle stiffness or pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alparsan Turan, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least 3 months and those who had never used statins were considered to be eligible for participation. We included patients scheduled for elective surgery (October 2009 between June 2010) in this comparative, prospective, nonrandomized study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Statin Use Group | Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds |
| FG001 | Non Statin Use | Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Statin Use Group | Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds. |
| BG001 | Non Statin Use |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Myoglobin Concentration | Posted | Median | Inter-Quartile Range | ug/l | induction, 5 minutes after administration, 20 minutes and 24 hours post operatively |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Statin Users |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alparslan Turan, M.D. | Cleveland Clinic | 216-444-4000 | 9857 | turana@ccf.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| D013390 | Succinylcholine |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| 2 and 24 hours postoperatively |
| Serum Potassium Concentration | At 5 and 20 min after succinylcholine |
| Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively | Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively | 2 and 24 hours postoperatively |
| Duration of Succinylcholine Block | Time required to reach maximum block by succinylcholine after succinylcholine administration. | intraoperative: from succinylcholine administration |
| Fasciculation | The fasciculation ranges from 0 to 3: 0 none; 1 small movements around eyes and fingers; 2 moderate movements in face, neck, fingers, and trunk; and 3 vigorous movements in trunk and extremities. | postoperative |
Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Muscle Pain | verbal rating scale score and the pain score both at 2 and 24 hours postoperatively. The verbal rating scale score ranges from 0 (no pain) to 100 (worst pain imaginable). The pain score ranges from 0 to 3: 0 none; 1 muscle stiffness or pain in the nape of the neck, shoulders, and chest; 2 muscle stiffness and pain requiring analgesia; and 3 incapacitating generalized muscle stiffness or pain. | Posted | Number | participants | 2 and 24 hours postoperatively |
|
|
|
| Secondary | Serum Potassium Concentration | Two patients in non-statin group had missing value at 20 minute. | Posted | Median | Inter-Quartile Range | mEq/l | At 5 and 20 min after succinylcholine |
|
|
|
| Secondary | Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively | Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively | Two patients in the nonstatin group had missing CK value at 2 hour | Posted | Median | Inter-Quartile Range | units/l | 2 and 24 hours postoperatively |
|
|
|
| Secondary | Duration of Succinylcholine Block | Time required to reach maximum block by succinylcholine after succinylcholine administration. | Posted | Median | Inter-Quartile Range | minute | intraoperative: from succinylcholine administration |
|
|
|
| Secondary | Fasciculation | The fasciculation ranges from 0 to 3: 0 none; 1 small movements around eyes and fingers; 2 moderate movements in face, neck, fingers, and trunk; and 3 vigorous movements in trunk and extremities. | Posted | Number | participants | postoperative |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Nonstatin Users | 0 | 32 | 0 | 32 |
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| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
| D009930 |
| Organic Chemicals |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009861 | Onium Compounds |
| VRS score at 2 hour: 40-70 |
|
| VRS score at 2 hour: 80-100 |
|
| VRS score at 24 hour: 0 (no pain) |
|
| VRS score at 24 hour: 10-30 |
|
| VRS score at 24 hour: 40-70 |
|
| VRS score at 24 hour: 80-100 |
|
| Pain score at 2 hour: 0 (no pain) |
|
| Pain score at 2 hour: 1 |
|
| Pain score at 2 hour: 2 |
|
| Pain score at 24 hour: 0 (no pain) |
|
| Pain score at 24 hour: 1 |
|
| Pain score at 24 hour: 2 |
|
| Moderate |
|
| Vigorous |
|